A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects (αHLA-G Exo-01)

Shine-On Biomedical Co., Ltd.

Status and phase

Enrolling

Phase 1

Conditions

Targeted Therapy

Healthy Subjects

Exosome

Treatments

Drug: SOB100

Study type

Interventional

Funder types

Industry

Identifiers

NCT07219940

SOB100-CL-Proto-01

Details and patient eligibility

About

The investigational drug, SOB100, is an HLA-G targeted exosome equipped with a nanobody namely anti-HLA-G VHH on the exosome membrane. This is a Phase I dose escalation study to exam the tolerability, safety, and pharmacokinetics in healthy subjects.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female subjects aged ≥ 18 years old
Overtly healthy subject, who is considered to be generally healthy based on medical history, 12-lead ECG, and physical examinations, as judged by the Investigator
Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF)
Adequate organ function

Exclusion criteria

With known or suspected to be hypersensitivity to HLA-G related treatment.
Confirmed active HIV, HBV, or HCV infection
With active fungal, bacterial, viral or atypical infection requiring systemic medication
History of cancer (malignancy) or have ever received any anti-cancer therapy
Has ever received cell therapy or organ transplantation
Substance abuse or addictive use of drugs for nonmedical purposes
Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception
Male subjects with a female spouse/partner who is of childbearing potential refuse to adopt at least one highly effective method of contraception